Inspired by War Zones, Balloon Device May Save Civilians From Fatal Blood Loss

Their invention, made by Prytime Medical and cleared by the Food and Drug Administration in 2015, is gradually being adopted in civilian trauma centers around the country and has recently been used by the military. But medical teams need rigorous training to use it: Mishandled, it can be dangerous.

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Dr. Bukur punctured Ms. Williams’s thigh, threaded a slim tube into her femoral artery and eased it up about 12 inches into her aorta, the major artery that carries blood from the heart to most of the body. Then he injected salt water to inflate a balloon near the tip of the tube, blocking the aorta and cutting off circulation to Ms. Williams’s pelvis and legs. Above the balloon, blood still flowed normally to her brain, heart, lungs and other vital organs.

Almost instantly, her blood pressure rose and her racing heart slowed down. The balloon stopped the hemorrhaging inside her pelvis, almost like turning off a faucet. Reboa stands for resuscitative endovascular balloon occlusion of the aorta, but some doctors describe it simply as an “internal tourniquet.”

The clock was ticking. Circulation could be safely cut off for only so long — ideally, no more than about 30 minutes. Beyond that, the lack of blood flow could severely damage Ms. Williams’s legs and internal organs. The balloon had only bought the medical team a bit of time to find the source of the blood loss and fix it. If they failed, when they deflated the balloon they would be back where they started, with Ms. Williams on the verge of bleeding to death.

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Jessica Ann Williams in her high school yearbook picture.

In New York City, Dr. Sheldon H. Teperman, director of trauma and critical care services at NYC Health & Hospitals/Jacobi, and Dr. Aksim G. Rivera, a vascular surgeon there, have been teaching the procedure to trauma surgeons at city hospitals and other medical centers in the area. Bellevue surgeons trained with them.

A Jacobi team led by the trauma surgeon Dr. Edward Chao was the first in the city to use the ER-Reboa, in February. Their patient, Nanetta Hall, 60, a manager in the city’s Human Resources Administration, had been run over by a pickup truck. Like Ms. Williams, she nearly died from internal hemorrhaging caused by pelvic injuries.

“It’s a lifesaving instrument, but it needs to be handled with respect because turning off the blood supply to half the body is dangerous,” Dr. Teperman said, adding, “I lie awake at night worrying that maybe someone will use it improperly.”

Several patients in Japan had to have legs amputated after being treated with a related device that was left inflated for too long.

The idea for the ER-Reboa catheter came to Dr. Todd E. Rasmussen and Dr. Jonathan L. Eliason in 2006, while they were deployed as surgeons in Iraq. Improved tourniquets and transfusion techniques did prevent soldiers from bleeding to death from wounds in their arms and legs. But there was no similar solution for bleeding in the abdomen or pelvis, or what doctors call “noncompressible hemorrhage.”

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The two doctors, both vascular surgeons, started to develop a new device based on an older balloon catheter designed to prevent bleeding in people having surgery on the aorta.

The older device can be used on trauma victims, but not easily. It is large and complex, and meant for use by vascular surgeons with X-rays to guide it. It was “really designed to be used in nice surgery centers, with well-staffed, fancy operating rooms,” said Dr. Rasmussen, an Air Force colonel, who is associate dean for research and an attending surgeon at the military medical school and medical center at the Uniformed Services University in Bethesda, Md.

“None of that translates well into when all hell is breaking loose and your patient is going to die in seven minutes,” said David Spencer, the president of Prytime Medical.

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The ER-Reboa.Credit
Sam Hodgson for The New York Times

Dr. Rasmussen and Dr. Eliason set out to create a smaller, stripped-down version that could be placed quickly inside the aorta without X-rays by trauma surgeons and, eventually, by general surgeons, emergency room doctors and maybe medics.

Those doctors and medics are usually the first to reach people who are bleeding, in what trauma experts call the “golden hour” after an injury, Dr. Rasmussen said, adding, “That’s where the margin to save lives is greatest.”

By 2009, he and Dr. Eliason made a prototype, nicknamed their “Home Depot version” of the device.

“It was pretty clunky,” Dr. Rasmussen said. But it was good enough to start testing in the lab. The results were promising, but large, traditional medical device companies showed no interest in developing it.

After a talk Dr. Rasmussen gave in 2009 that mentioned the lack of commercial interest in military medical research, Mr. Spencer, a technology entrepreneur and venture capitalist from San Antonio, offered to start a company to make and market the device. A self-described Army brat, Mr. Spencer said he liked the idea that something inspired by a military need could also save civilian lives.

The catheters, used once and then thrown away, cost about $2,000, which is relatively cheap compared with other devices used in vascular surgery. The ER in the product name stands for the last names of the two inventors, Eliason and Rasmussen.

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The Defense Department and the University of Michigan hold the patent, Dr. Rasmussen said, and he makes no money from it.

People with pelvic injuries, like Ms. Williams and Ms. Hall, are ideal candidates for Reboa, surgeons say. Those injuries are a notorious cause of life-threatening hemorrhage. When the body is hit hard enough to break the pelvis, the impact almost always shears or severs hundreds of tiny veins and arteries that bleed profusely. Bleeding in the pelvis can be difficult or impossible to stop, because the area often cannot be compressed enough.